K-924 Phase III Confirmatory Study

Phase 3 Completed 293 enrolled Kowa Company, Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

A multicenter, active-controlled, randomized, double-blind comparative study to compare the efficacy and safety of K-924 LD tablet or K-924 HD tablet to pitavastatin 2 mg or 4 mg in patienta with hypercholesterolemia.

Timeline

Start: 2020-04-02
Primary completion: 2020-11-21
Completion: 2020-11-21

Outcome

Met primary endpoint

paper Compared with pitavastatin monotherapy, the pitavastatin/ezetimibe fixed-dose combination significantly reduced LDL-C PMID 36908150 ↗

Publications

Results Tsujita K, Yokote K, Ako J, Tanigawa R, Tajima S, Suganami H. Efficacy and Safety of Pitavastatin/Ezetimibe Fixed-Dose Combination vs. Pitavastatin: Phase III, Double-Blind, Randomized Controlled Trial. J Atheroscler Thromb. 2023 Nov 1;30(11):1580-1600. doi: 10.5551/jat.64006. Epub 2023 Mar 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ezetimibe	Unknown	10 mg	—
Subject	Pitavastatin	Small molecule	2 mg	—
Subject	Pitavastatin	Small molecule	4 mg	—